Is Biogen Idec's Fast Track Status on MS Candidate a Game Changer? (BIIB, ELN)

July 9, 2009 · Filed Under fda, multiple sclerosis 

Biogen Idec (NASDAQ: BIIB) has been having issues with its MS franchise TYSABRI for what is becoming a multi-year event.  It already has a blockbuster with its AVONEX for RMS.  But the stock is enjoying a second day of gains today after its “other” Multiple Sclerosis treatment has received an FDA Fast Track Designation.  The announcement was made on Wednesday that its PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) received the designation.

Our take has long been that TYSABRI has been given a bit of a bad wrap because of the PML cases.  It isn’t that this is not an issue.  Having spoken with multiple TYSABRI users and family members of theirs over the years, it is our opinion that most users feel that TYSABRI is worth the risk as the PML cases are so isolated.  But it would be foolish to not acknowledge that this has significantly lowered the number of TYSABRI ‘clients.’

After looking through the data, it seems that there is a chance that this PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis could end up being a significant game changer for the company.  With a risk, of course.  Elan Corp. plc (NYSE: ELN) is the TYSABRI partner, and while recent developments may help Elan it has spent its time in and out of being considered a “troubled stock” for longer than memory would serve.

Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.

The company has noted that early-stage clinical trials suggest that the new candidate has the potential to offer less frequent dosing without compromising efficacy.  Biogen Idec is also going to work closely with the FDA to expedite the compound’s development and review process.  The FDA’s Fast Track designation program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.  It is not the same as an Oprhan Drug designation status, but it can create a situation of faster approval and ultimately much less costly of an approval process.  Blockbuster drugs often come with near-blockbuster costs from start to final marketing approval.

Biogen Idec will enroll more than 1,200 patients in the Phase III, randomized, double-blind, placebo-controlled trial to evaluate the PEGylated interferon beta-1a in patients with RMS.

The global trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS at one year. The study will also examine if, over time, treatment with PEGylated interferon beta-1a can slow disease progression and lead to a decrease in the number of T2 hyperintense brain lesions commonly seen in MS patients.

This could represent a new treatment.  That could lure many TYSABRI candidates who are not taking TYSABRI.  There are thousands and thousands of these candidates.  But, as noted, there is a risk.  Cannibalization can occur.  It might even be an expected outcome.  We cannot make that assumption without having detailed Phase III and post-trial data nor without speaking to TYSABRI users or their family members.  But the same goes for sale of its AVONEX for RMS.

To show the data from the annual report for 2008, AVONEX was on the market in over 70 countries, and the company  believes that AVONEX is the most prescribed therapeutic product for the treatment of MS worldwide with over 135,000 patients using AVONEX.

Also from the annual report, TYSABRI had approximately 37,000 patients at the end of 2008 worldwide, and the company gave a cumulative figure of approximately 48,300 patients having been treated with TYSABRI in the post-marketing setting since approval in 2004.

The company listed total 2008 counted revenues for AVONEX as $2.2026 billion, as compared to $1.8678 billion in 2007.  For TYSABRI, that figure for 2008 was carried as $588.6 million, up from $229.9 million in 2007.

The PEGylated interferon beta-1a may or may not ultimately take away anything from the collective revenues of TYSABRI and AVONEX.  Many drugs are progressive treatments and patients often switch because of a developed resistance or for a dozen other reasons.  How that plays out still has too many variables to calculate.

This could be a game changer in the war against treating MS.  With risks.

Jon C. Ogg
July 9, 2009

Tags: ,

Comments

Comments are closed.

    Subscribe to BioHealth Investor BioHealth Investor RSS Feed